Radius Loop ELectrodes

GUDID GYNX1220081

GYNEX CORPORATION

Electrocautery system electrode
Primary Device IDGYNX1220081
NIH Device Record Keyd8c218bc-c398-4c03-9430-f9bef4a91f0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadius Loop ELectrodes
Version Model Number12-2008
Company DUNS012997685
Company NameGYNEX CORPORATION
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCGYNX1220080 [Unit of Use]
HIBCCGYNX1220081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGIElectrocautery, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-04

On-Brand Devices [Radius Loop ELectrodes]

GYNX122515112-2515
GYNX122510112-2510
GYNX122015112-2015
GYNX122010112-2010
GYNX122008112-2008
GYNX121515112-1515
GYNX121512112-1512
GYNX121508112-1508
GYNX121505112-1505
GYNX121023112-2013
GYNX121010112-1010
GYNX121007112-1007
GYNX120505112-0505

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